The natural heart functions in a fashion similar to a positive displacement pump. Each of the two pumping chambers in the natural heart has two check valves (an inlet and an outlet valve). The walls of the natural heart are made of contractile muscle that provide the power to pump the blood. Each pumping cycle consists of a filling or diastolic phase of the pumping cycle and an ejection or systolic phase of the pumping cycle. During the filling phase, the muscle fibers making up the walls of the heart relax allowing the chamber they surround to fill with blood. During the ejection phase of the cycle the muscle making up the walls of the heart contracts ejecting a portion of the blood from the chamber. The check valves assure one-way flow.
Mechanical blood pumps have been developed for use as artificial hearts to replace or assist the natural heart. Present blood pumps which are available to assist or replace the heart fall into two general categories. One category uses a rotary impeller and includes centrifugal pumps and axial flow pumps. The other category is pulsatile pumps, the diaphragm type pump being the most common. Blood pumps may also be classified as internal (intracorporeal) or external (extracorporeal) to the body.
Diaphragm pumps are favored as they provide desirable pulsative flow and are reliable owing to their simplicity. Prior art diaphragm pumps comprise a housing, a flexible but not extensible diaphragm that divides the interior of the housing into two chambers, namely a pumping chamber and a driving chamber. Diaphragms are conventionally fabricated from polyurethane, a flexible but not elastic material. The pumping chamber portion of the housing has an inlet and an outlet, each of which is equipped with a one-way flow check valve. The diaphragm is driven into and out of the pumping chamber mechanically, pneumatically or hydraulically. Mechanical drives typically include a pusher plate on the drive side of the diaphragm connected to a cam, solenoid or other device to impart reciprocal motion to the pusher plate and diaphragm. Alternatively, a drive fluid, either liquid or gas, may be used to reciprocally drive the diaphragm into and out of the pumping chamber.
One of the problems associated with available mechanical blood pumps is the formation of blood clots (thrombosis) in the pump. To address this problem, the interior surfaces of the diaphragm and housing walls that define the pumping chamber are typically designed to have a very smooth surface, in an effort to retard clotting. Other attempts to reduce clotting have involved provision of a rough texture on the interior surfaces of the pumping chamber to encourage endothelial cells, normally lining the heart and blood vessels, to grow over the surfaces eventually providing a smooth surface. Both of these methods work to some degree, but clotting in the device, with clots breaking off and entering the circulatory system, remains a problem.
Another problem relates to the flow of blood through the pump. Significant turbulence occurs in the chamber during the pumping cycle. There is little that can be done to control the characteristics of blood flow through the pumping chamber. There are areas of high velocity and other areas of slow flow. These slow flow areas also contribute to clotting. Turbulence leads to energy loss and inefficiency of the pump. Excessive turbulence may also damage the blood cells.
An additional problem is rupture of the diaphragm. If the diaphragm is driven pneumatically or hydraulically, should a tear or rupture of the diaphragm occur, the driving fluid may be pumped into the bloodstream, causing a harmful and potentially fatal embolism. Even if the pump is mechanically driven, a diaphragm rupture can result in air entering the bloodstream causing an embolism.
The foregoing are long standing problems in the art that have defied solution. There is, therefore, a need in the field for an improved blood pump and ventricular assist device.